Approval of regulations and specifications for new, improved veterinary preparations, feed additives
How to get the service in a state agency (required documents):
- An application.
- A document confirming the authority of service recipient’s representative (when service recipient’s representative refers to).
- Regulatory and technical documentation for new and improved veterinary drugs, feed additives (hereinafter, referred to as RTD) in 2 (two) counterparts in the state and Russian languages, which includes:
- Veterinary drug and feed additive standardization document containing information on the structure in accordance with Annex 3 to the Rules.
- Instructions for veterinary drug and feed additive manufacture and control signed/approved by the developer or manufacturer of the veterinary drug, feed additive, containing information on the structure in accordance with Annex 5 to the Rules.
- A manual (instructions) on the application (use) of a veterinary drug and feed additive developed by the manufacturer containing information on the structure in accordance with Annex 5 to the Rules.
- A research study report on the veterinary drug and feed additive development, modification, improvement (hereinafter referred to as the research study report), as well as protocols (acts) of lab and production tests signed by the developer or manufacturer.
- A research study report for veterinary drugs used in medical treatment including information on pharmacokinetics, pharmacodynamics, toxicity (acute and chronic), teratogenicity and other required indicators of the active substance, drug stability, as well as reports/minutes / acts on the study of efficacy and safety of the veterinary product or its bioequivalence in the case of generic veterinary products.
- A research study report for vaccines including information on the safety, pathogenicity, biological activity, a virulence and other required indicators, drug stability as well as reports/minutes/ acts on the study of the veterinary drug efficacy (duration and intensity of immunity) and biological safety.
- A research study report for feed additives and veterinary drugs used for disinfection, deratization and disinfestation including the efficacy tests results.
- A research study report for veterinary drugs used in the diagnosis of the diseases, including the results of specificity, sensitivity, reproducibility tests.
- A passport for production and control strains of microorganisms and for continuous cell culture lines in the form in accordance with Annex 6 to the Rules (for veterinary drugs created using microorganisms, components of their cells, products of life activity intended for the treatment, prevention and diagnosis of animal diseases).
- A document confirming a veterinary drug and feed additive registration and/or inclusion in the state official pharmacopoeia of third countries, except for the member states of the Eurasian Economic Union (if any).
- A notary certified counterpart of agreement between manufacturer and patent owner of veterinary drug and feed additive components in the case of availability of patent (s) for separate veterinary drug and feed additive components (micro body strains used for the veterinary drug and feed additive manufacture/control) or for the veterinary drug and feed additive manufacture technology/method or its use/application.
- A document confirming permission to engage in activities for the production of veterinary drugs (for foreign manufacturers).
The service recipient, in addition to the documents, if available, shall submit documents certifying the production of veterinary drugs in accordance with international standard: (good manufacturing practice (GMP)).
The documents drawn up in other languages shall be submitted with a notary certified translation into the state and Russian languages.
Result of the service delivery
The agreement of regulatory and technical documentation for the new and improved veterinary drugs, feed additives, or a reasoned refusal to provide the public service.